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Partners in Health

ISO and WHO are working for universal access to quality health products that are all at once safe, effective, and affordable

Published: Tuesday, March 26, 2019 - 11:00

(ISO: Geneva) -- While some countries have made great progress toward universal health coverage, half the world’s population are still unable to obtain the health services they need. The International Organization for Standardization (ISO) and the World Health Organization (WHO) are working collaboratively to change things.

Good health should be a universal human right, but all too often it is dictated by social and geographical circumstances. Global health and well-being are the preserve of WHO, the directing and coordinating authority for health within the United Nations system. Created to dispense the advice and knowledge needed for people to lead healthy lives, WHO provides leadership on matters critical to health and engages in partnerships where joint action is needed. This aspiration toward better health for all has been the guiding principle for seven decades and is the impetus behind the organization’s drive toward universal health coverage.

Good health requires the commitment of many, from policy makers to civil society, to global health partners, and even standards makers. ISO has enjoyed a strong collaboration with WHO for many years; WHO participates in almost 60 liaisons with ISO technical committees to develop standards for mutual benefit. Both organizations agree on the importance of ensuring that health standards are in place everywhere in the world, to contribute to global well-being and to create the best possible conditions for health professionals to do their job.

The goal of these partnerships is to leverage international activities that contribute to the “tailoring” and adoption of ISO international standards for health systems across all kinds of sectors, from public health and medical products to health informatics and traditional medicines. At a time when there is disturbing evidence of widening gaps in health worldwide, ISOfocus asks François-Xavier Lery, Coordinator for Technologies Standards and Norms at the World Health Organization, how the collaboration with ISO can help advance universal health coverage in the 21st century.

ISOfocus: World Health Day is an occasion for raising awareness of key global health issues. What is the biggest health challenge that the world faces today?


François-Xavier Lery, Coordinator for Technologies Standards and Norms at the World Health Organization

François-Xavier Lery: The date of April 7, each year, marks the celebration of World Health Day, designed to create awareness of a health issue that is of primary concern to the World Health Organization [WHO]. Our top priority at WHO is universal health coverage, which has emerged as a key strategy to make progress toward other health-related and broader development goals. A vital pillar of universal health coverage is ensuring that all people have access to essential quality care and safe, effective, and affordable medicines, vaccines, and other health products. This enhances people’s health and life expectancy, protects countries from epidemics, reduces poverty, and drives economic growth.

Currently, at least half of the world’s population still has low or no access to health products, and 100 million people are pushed into “extreme poverty” because they have to pay for healthcare out of their own pockets. All United Nations member states have pledged to achieve universal health coverage by 2030 as part of the Sustainable Development Goals (SDGs), the United Nations’ global agenda for a better and more sustainable future for all.

ISOfocus: WHO participates in almost 60 ISO technical bodies that develop ISO standards. What are the benefits of this participation for WHO?

Lery: Over the years, WHO has developed 180 norms and standards for medicines, vaccines, and pharmaceuticals. These are used, in particular, for products subject to the WHO Prequalification Program, created with a view to ensuring that products procured by the United Nations are of assured quality and efficacy. The program has made an enormous contribution in terms of increasing the access to quality-assured health products that are affordable and adapted to markets in low- and middle-income countries.

In some very technical areas, such as the design and manufacture of syringes, WHO collaborates with, and relies on, ISO for elaborating and maintaining standards. This partnership guarantees that the standards designed within the ISO framework are fit for use by all countries, including those where access to healthcare remains difficult. These countries are not always represented in ISO technical committees and working groups; WHO ensures they are given a voice so that health products can be made accessible to all patients around the world while maintaining global standards.

ISOfocus: How can greater collaboration/synergy between ISO and WHO contribute to the 2030 Global Agenda—in particular [goal 3 of the Sustainable Development Goals] SDG 3, which aspires to “ensure healthy lives and promote well-being for all at all ages?”

Lery: WHO’s collaboration with ISO can facilitate the participation of policy makers, manufacturers, and healthcare professionals from low- and middle-income countries in ISO standardization work for the advancement of public health. The robust standardization process followed by ISO is sometimes perceived by actors from these countries as “very demanding”—good coordination helped by WHO should make it easier to develop ISO standards in an inclusive way. The ISO-WHO partnership also provides a good interface between technical standards and regulatory requirements, with a view to promoting access to high-quality health products.

ISOfocus: Why is the uptake/use of ISO standards so important?

Lery: ISO standards, just like WHO standards, are made to be used. Stakeholders, interested parties, and standardization bodies invest a lot of time and energy in their development so that they apply equally and fairly—from a business competition viewpoint—to all stakeholders and ensure quality products and services. Their uptake is therefore critically important. Appropriate use of standards also helps monitor products and services to ensure the timely revision of the standards that support them. Like ISO, WHO gives high priority to the implementation of standards. In fact, our new five-year plan, the General Program of Work 2019–2023, includes activities to better monitor the implementation of WHO norms and standards in order to encourage their positive impact on populations.

ISOfocus: What would you like to see in the near future (from ISO or elsewhere) in order to make SDG 3 a reality?

Lery: Universal health coverage hinges on universal access to quality health products that are all at once safe, effective, and affordable. This cannot happen without quality assurance of the products and services delivered to patients. SDG 3 will only become a reality if all stakeholders—and by that I mean policy makers, regulators, and standards-setting organizations—work together across countries, regions, and professional groups. Experience has shown that this can only be achieved when political will is strong.

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About The Author

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The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards. ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a nongovernmental organization that forms a bridge between the public and private sectors. ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. View the ISO Standards list.